Device and method for sealing blood vessels

ABSTRACT

The present invention provides devices, systems, and methods for percutaneously sealing a puncture site in tissue tracts and vessels in human or animal bodies. One system includes a locating assembly that is used to locate the puncture site and can also provide temporary hemostasis when the system is used for closing a vessel puncture. The system also includes a compression assembly comprising a tubular member with a balloon on a distal end thereof. This balloon is at a fixed distance from the locator tip which locates the balloon outside the vessel wall at a predetermined distance. Inflation of this balloon causes forward elongation of the balloon which compresses subcutaneous tissue between the distal tip of the balloon and the vessel wall. This tissue compression against the puncture site is the mechanism that provides hemostasis.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.10/821,633 (Attorney Docket No. 28863-713.201), filed Apr. 9, 2004, nowU.S. Pat. No. ______, the entire content of which is incorporated hereinby reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to devices, systems, and methodsfor percutaneous sealing of a puncture site in tissue tracts. Morespecifically, the present invention relates to devices, systems, andmethods for hemostasis of vascular puncture sites in human bodies.

Percutaneous access of blood vessels in the human body is routinelyperformed for diagnostics or interventional procedures such as coronaryand peripheral angiography, angioplasty, atherectomies, placement ofvascular stents, coronary retroperfusion and retroinfusion, cerebralangiograms, treatment of strokes, cerebral aneurysms, and the like.Patients undergoing these procedures are often treated withanti-coagulants such as heparin, thrombolytics, and the like, which makethe closure and hemostasis process of the puncture site in the vesselwall at the completion of such interventional procedures more difficultto achieve.

Various devices have been introduced to provide hemostasis, however nonehave been entirely successful. Some devices utilize collagen or otherbiological plugs to seal the puncture site. Alternatively, suturesand/or staples have also been applied to close the puncture site.External foreign objects such as plugs, sutures, or staples however maycause tissue reaction, inflammation, and/or infection as they all “leavesomething behind” to achieve hemostasis.

There is also another class of devices that use the body's own naturalmechanism to achieve hemostasis wherein no foreign objects are leftbehind. Such devices typically provide hemostasis by sealing thepuncture site from the inside of the vessel wall wherein the device isleft in place in the vessel lumen until hemostasis is reached andthereafter removed. Although such devices have achieved relative levelsof success, removal of the device at times may disrupt the coagulantthat is formed at the puncture site. This in turn may cause residualbleeding which requires the device user to apply a few minutes ofexternal manual pressure at the puncture site after the removal of thedevice to achieve complete hemostasis.

Still further devices that also uses body's natural mechanism to achievehemostasis comprise a locator on the inside of the vessel wall and aballoon to directly contact and seal the puncture site from the outsidesurface of the vessel wall. This balloon is directly against and incontact with the outside surface of the vessel wall for sealing the holeand achieving hemostasis. There are several drawbacks associated withdirect contact and compression of the outside surface of the vesselwall. For example, excessive compression may cause herniation of theballoon through the puncture site into the vessel, which in turn maycause resumption of bleeding. Further, such devices may not be easilyapplied to severely tortuous vessels where direct access and contactwith the vessel surface to seal the puncture may be difficult toachieve. Moreover, such devices may substantially disrupt the flow ofblood in the vessel during its application. Further, intimate devicecontact with the puncture site of the vessel wall may not providesufficient coagulant. Still further, removal of the device may causedisruption of the coagulant at the puncture site thereby increasing thechances for resumption of bleeding and hematoma formation (i.e., leakingof blood into interstitial space).

In light of the above, it would be desirable to provide improveddevices, systems, and methods for complete hemostasis of a puncture sitein a body lumen, particularly blood vessels of the human body. It wouldbe particularly desirable if such devices, systems, and methods utilizedthe body's own natural healing mechanism to achieve hemostasis withoutdisrupting coagulation formation at the puncture site. It would befurther desirable if such devices, systems, and methods prevented anyvessel herniation or vessel flow disruption.

Further, such devices, systems, and methods should be easy to implementon a variety of vessel anatomies. At least some of these objectives willbe met by the devices, systems, and methods of the present inventiondescribed hereinafter.

2. Background of the Invention

Expansible devices for use in blood vessels and tracts in the body aredescribed in co-pending U.S. patent application Ser. No. 10/718,504,assigned to the assignee of the present application. The following U.S.patents and publications may be relevant to the present invention: U.S.Pat. Nos. 4,744,364; 4,852,568; 4,890,612; 5,108,421; 5,171,259;5,258,000; 5,383,896; 5,419,765; 5,454,833; 5,626,601; 5,630,833;5,634,936; 5,728,134; 5,861,003; 5,868,778; 5,951,583; 5,957,952;6,017,359; 6,048,358; 6,296,657; U.S. Publication Nos. 2002/0133123 and2003/0055454.

The full disclosures of each of the above mentioned references areincorporated herein by reference.

BRIEF SUMMARY OF THE INVENTION

The present invention provides improved devices, systems, and methodsfor complete hemostasis of a puncture site in a body lumen, particularlyblood vessels of the human body. Such closure devices, systems, andmethods utilize the body's own natural healing mechanism to achievehemostasis without leaving any foreign objects behind. The devices ofthe present invention allow for enhanced coagulant formation at thepuncture site, increasing the integrity of hemostasis. Further, removalof such sealing devices and systems after hemostasis is achieved doesnot incite disruption of the coagulation formation at the puncture site.This in turn reduces the risk of bleeding and hematoma formation,thrombosis, embolization, and infection. The devices, systems, andmethods of the present invention substantially avoid dangers of vesselherniation or vessel flow disruption, particularly in lower extremities.Further, such devices, systems, and methods are easy to implementwithout numerous intermediary steps on a variety of vessel anatomies,such as severely tortuous vessels.

In a first aspect of the present invention, a system for hemostasis of apuncture site in a body lumen is provided. One system comprises alocating assembly and a compression assembly. The locating assemblygenerally comprises a first tubular member having a proximal end and adistal end and an expansible member disposed on the distal end of thefirst tubular member. The compression assembly is at least partiallycoaxial with the locating assembly. The compression assembly comprises asecond tubular member having a proximal end and a distal end and aballoon disposed at the distal end of the second tubular member. Inparticular, a distal end of the balloon is positionable at apredetermined distance away from a wall of the body lumen. An inflationassembly is also provided. It is coupleable to a proximal end of thecompression assembly and in communication with the balloon.

Hence, the present invention is designed such that the compressionballoon is deployed outside the vessel wall at a predetermined distancefrom the outside surface of the vessel wall. The balloon, duringinflation, compresses the subcutaneous tissue between the vessel walland the distal surface of the balloon. The compressed tissue can thenovercome the blood pressure and hence stop blood from flowing out toachieve hemostasis. It will be appreciated that the balloon is not usedas means to directly contact and seal the hole in the vessel wall.Rather, the present invention uses the tissue as the compression mediumagainst the puncture site to achieve hemostasis. The tissue left betweenthe balloon and the vessel wall allows for enhanced coagulation in thevicinity of the puncture site. This allows for more secure hemostasiswith reduced chances of delayed bleeding.

The locating assembly further comprises deployment means coupleable tothe proximal end of the first tubular member so as to move theexpansible member between a contracted configuration and an expandedconfiguration. The expansible member in the expanded configurationtypically has a diameter in a range from about 0.05 inch to about 0.5inch, preferably in a range from about 0.15 inch to about 0.30 inch. Theexpansible member generally comprises stainless steel, shape memorymaterial, superelastic material or like medical grade material. Thelocating assembly may further comprise a temporary hemostasis member,such as a plug, coupleable to the distal end of the first tubularmember. In some embodiments, the compression balloon may be disposedbetween the distal end of the second tubular member and a proximal endof the temporary hemostasis member so as to form an integrated, unitaryassembly. In other embodiments, it is preferable that the balloon isdisposed solely on the distal end of the compression assembly, asdescribed in more detail below. In still other embodiments, the locatingassembly may further comprise a deformable membrane at least partiallydisposed over the expansible member in lieu or in addition to thetemporary hemostasis plug.

Generally, the compression balloon remains proximal a distal end of theexpansible member. This predetermined positioning may be implemented inany number of ways. For example, mechanical or visual means on thelocating or compression assembly like detents, latches, flanges, othermechanical interference, visual markings, and like mechanisms, mayprovide positioning of the compression balloon at a fixed distance fromthe expansible member which locates the balloon outside the vessel wallat the predetermined distance. The predetermined distance of the distalend of the compression balloon from the vessel wall is in a range fromabout 0.05 inch to about 0.5 inch, preferably in a range from about 0.2inch to about 0.3 inch. The compression assembly may be fixed relativeto the locating assembly. Alternatively, the compression assembly may bemoveable relative to the locating assembly.

In some instances, the locating assembly may be laterally offset from anaxis of the compression assembly. As discussed above, the locatingassembly and compression assembly may also form an integrated catheterassembly structure for ease of operation.

The compression balloon may comprise one or more materials selected fromthe group consisting of polyethylene, polyethylene terephthalate,polytetrafluroethylene, nylon, polyurethane, silicone, latex, polyvinylchloride, and thermoplastic elastomer. The compression balloon may bepre-formed or pre-molded symmetrically or asymmetrically. In someembodiments, the balloon has an expanded configuration comprising aconical shape. In other embodiments, the balloon comprises a pluralityof concentric folds that are unfolded in an expanded configuration. Infurther embodiments, the balloon has an expanded configurationcomprising a concave distal end. This last design allows for formationof a concave surface relative to the vessel wall when the balloon isinflated, allowing for more coagulant to form at the puncture site whichwould likely provide for enhanced hemostasis.

The compression assembly may further comprise a radio-opaque material sothat the compression balloon placement may be imaged and viewed viafluoroscopy. In some embodiments, a coating on an outer surface of theballoon may be applied. The coating may comprise electrically conductivematerial for the delivery of energy, such as radio frequency energy ormicrowave energy to further promote and accelerate complete hemostasis.The coating may further be designed to deliver ultrasound energy.Alternatively, the coating may comprise clot promoting agents, such asthrombin, or anti-infection agents. In the case of agent release, theballoon may alternatively comprise a semi-permeable membrane, allowingthe inflation medium, which may be chosen from clot promoting solutions,to diffuse into the surrounding tissue. The inflation assembly generallycomprises a source of at least air, fluid, clot promoting agent,anti-infection agent, radio-opaque medium, or a combination thereof.

In another aspect of the present invention, devices for hemostasis of apuncture site in a body lumen are also provided. One device comprises afirst tubular member having a proximal end and a distal end and a secondtubular member having a proximal end and a distal end. The secondtubular member is at least partially coaxial with the first tubularmember so as to define an inflation lumen therebetween. A balloon isdisposed at the distal ends of the first and second tubular members andin communication with the inflation lumen. A distal end of the balloonis postionable at a predetermined distance away from a wall of the bodylumen. The characteristics of the compression balloon are generally asdescribed above. In an additional embodiment, the balloon may comprisean expansible member and a deformable membrane at least partiallydisposed over the expansible member as described in greater detail inco-pending U.S. patent application Ser. No. 10/718,504, assigned to theassignee of the present application and incorporated herein byreference.

In yet another aspect of the present invention, methods for hemostasisof a puncture site in a body lumen are also provided. One methodcomprises providing a compression assembly comprising a tubular memberhaving a proximal end and a distal end and a balloon disposed at thedistal end of the tubular member. The compression assembly is insertedthrough an opening in a skin surface. A distal end of the balloon ispositioned at a predetermined distance away from a wall of the bodylumen and against subcutaneous tissue. The balloon is inflated to anexpanded configuration. This causes forward elongation of the balloonwhich compresses subcutaneous tissue between the distal tip of theballoon and the vessel wall. This tissue compression against thepuncture site is the mechanism that provides hemostasis. As describedabove, the balloon is only engageable against subcutaneous tissuesurrounding the body lumen wall, wherein the body lumen comprises ablood vessel. The predetermined distance may be in a range from about0.05 inch to about 0.5 inch, preferably in a range from about 0.2 inchto about 0.3 inch. The balloon may be imaged during positioning.Further, radio frequency energy, ultrasound energy, microwave energy,clot promoting agents or anti-infection agents may be delivered to thepuncture site.

Since the compression assembly of the present invention is seatedagainst the subcutaneous tissue, and is not in contact with the vesselwall, there is further coagulant formation and less chances ofdisruption of the coagulant at the puncture site (e.g., arteriotomysite) when the device is removed. It is thus expected that the chancesof resumption of bleeding or complications such as formation of hematomaare greatly reduced. Further, since the compression balloon is at apredetermined distance away from the vessel wall and againstsubcutaneous tissue, the risks of the balloon herniating into thepuncture site and into the vessel are greatly reduced. Moreover, as thecompression assembly relies on tissue compression and not intimate andcomplete seating of the balloon around the periphery of the puncturesite to achieve sealing of the hole, it can therefore be applied withless precision and is less dependant on the anatomy of the site. Inother words, the compression assembly is more forgiving in itsapplication since it is less reliant on positioning and as such may beeven applied to seal severely tortuous vessels. The compression assemblycan also be used more reliably and therefore has a greater chance ofsuccess.

The proposed design of the balloon and the attachment technique providefor forward movement of the distal end of the balloon towards the vesselwall, causing tissue compression, when inflated. For example, inflatingmay comprise at least one of axial or radial dilation of the balloon soas to cause targeted micro compression of the subcutaneous tissuesurrounding the body lumen wall. Alternatively, inflating may compriseexpanding a superior aspect of the balloon greater than an inferioraspect of the balloon. Since the tubular member is often not positionedperpendicularly to the vessel, this embodiment compensates for thedifference in the distance between the top distal tip of the balloon tothe vessel wall and the bottom distal tip of the balloon to the vesselwall so as to provide for more even compression over the puncture site.Optionally, inflating may comprise expanding a distal face of theballoon at an angle to the tubular member similar to an angle formedbetween the tubular member and the body lumen. Inflating may alsocomprise simply deploying the balloon to an expanded configurationcomprising a conical shape. Still further, inflating may compriseunfolding concentric folds of the balloon to an expanded configurationor deploying the balloon to an expanded configuration having a concavedistal end.

A locating assembly comprising a second tubular member having a proximalend and a distal end and an expansible member disposed on the distal endof the second tubular member is also preferably provided. The locatingassembly may be inserted through the opening in the skin and in thepuncture site prior to or simultaneously with compression assemblyinsertion. The expansible member is deployed to an expandedconfiguration within the body lumen having a diameter in a range fromabout 0.05 inch to about 0.5 inch. The puncture site in the body lumenwall is then located and temporary hemostasis of the puncture site witha plug coupleable to the distal end of the second tubular member mayalso be provided. After balloon inflation and initial compression, thelocating assembly is contracted and withdrawn from the skin.

A further understanding of the nature and advantages of the presentinvention will become apparent by reference to the remaining portions ofthe specification and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The following drawings should be read with reference to the detaileddescription. Like numbers in different drawings refer to like elements.The drawings, which are not necessarily to scale, illustratively depictembodiments of the present invention and are not intended to limit thescope of the invention.

FIGS. 1A and 1B illustrate a locating assembly in an expandedconfiguration and retracted configuration respectively.

FIG. 1C illustrates a balloon compression assembly in a collapsedconfiguration.

FIG. 1D illustrates a system for hemostasis of a puncture site in a bodylumen employing the assemblies of FIGS. 1A-1C constructed in accordancewith the principles of the present invention.

FIGS. 2A and 2B illustrate another embodiment of the locating assemblyin a retracted configuration and an expanded configuration respectivelythat may be employed in any of the systems disclosed herein.

FIGS. 3A and 3B illustrate yet another embodiment of the locatingassembly in a retracted configuration and an expanded configurationrespectively that may be employed in any of the systems disclosedherein.

FIGS. 4A and 4B illustrate another embodiment of the balloon that may beemployed in any of the compression assemblies disclosed herein.

FIGS. 5A through 5C illustrate yet another embodiment of the balloonthat may be employed in any of the compression assemblies disclosedherein.

FIGS. 6A and 6B illustrate a further embodiment of the balloon that maybe employed in any of the compression assemblies disclosed herein.

FIGS. 7A through 7C illustrate a still further embodiment of the balloonthat may be employed in any of the compression assemblies disclosedherein.

FIGS. 8A through 8G illustrate a method for hemostasis of a puncturesite in a body lumen employing the system of FIG. 1D.

FIGS. 9A through 9C illustrate another system embodiment for hemostasisof a puncture site in a body lumen constructed in accordance with theprinciples of the present invention.

FIG. 10 illustrates yet another system embodiment for hemostasis of apuncture site in a body lumen constructed in accordance with theprinciples of the present invention.

FIGS. 11A through 11C illustrate a further system embodiment forhemostasis of a puncture site in a body lumen constructed in accordancewith the principles of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIGS. 1A through 1D, an exemplary embodiment of a system 10for hemostasis of a puncture site in a body lumen constructed inaccordance with the principles of the present invention is illustrated.The system generally comprises a locating/temporary hemostasis assembly11 as illustrated in FIG. 1 A and a compression assembly 50 asillustrated in FIG. 1C. The locating/temporary hemostasis assembly 11comprises a flexible elongated tubular member 12 and a locating feature13. The locating feature 13 comprises an expansible member which canmove between an expanded state, as shown in FIG. 1A, and a contractedstate, as shown in FIG. 1B. A membrane may be present that fully orpartially covers this expansible member 13. Deployment means of theexpansible member 13 located at a proximal end of the tubular member 12may comprise a handle 14 and push/pull member 15 combination. The handleassembly 14 at the proximal end can facilitate the movement of theexpansible member 13 via the push/pull member 15 which connects thehandle assembly 14 to the expansible member 13. This member 15 may be inthe form of a wire of sufficient column strength to deploy and retractthe expansible member 13. It will be appreciated that the abovedepictions are for illustrative purposes only and do not necessarilyreflect the actual shape, size, or dimensions of the system 10. Thisapplies to all depictions hereinafter.

A distal end of tubular member 12, just proximal to the expansiblemember 13, is of sufficient diameter to temporarily seal the puncture inthe vessel wall. Hemostasis plug 16 temporarily stops bleeding while thecompression balloon is being deployed. The temporary hemostasis plug 16is tapered at a proximal end 17 to facilitate its use and avoid anypotential binding. Plug 16 may have a minimum length of 0.05 inch or itmay extend the entire length of the tubular member 12. Plug 16 may havea diameter in range from about 0.04 inch to about 0.2 inch. Theeffectiveness of the plug 16 to achieve temporary hemostasis may dependon a sheath size and the extent of the dilation of the puncture site. Insuch cases, the assembly 11 may be designed and manufactured to be usedin conjunction with a specific size or a range of sheath sizes.Temporary hemostasis plug 16 may then be tailored accordingly. Forexample, procedures using a 5 to 6 Fr sheaths may have a temporaryhemostasis plug that is approximately 0.070 inch in diameter. Thisdiameter is large enough to produce temporary hemostasis yet smallenough to go through a 5 Fr sheath. Plug 16 may also fully or partiallyhouse the contracted expansible member 13. It is generally desirable toremove the sheath once the closure assembly 11 is applied. Therefore,locating/temporary hemostasis assembly 11 may have a smallercross-sectional profile than an inside diameter of the sheath used.

Referring now to FIG. 1C, the compression assembly 50 of the hemostasissystem 10 includes elongated tubular membel^(l)s 51 and 53 andcompression balloon 55. An inner diameter of first tubular member 51 islarge enough so that it can preferably accept all, or at least a portionof the locating/temporary hemostasis assembly 11. As shown, a proximalend of compression tubular member 51 is equipped with a sealingmechanism 52 such as a silicone seal. Since compression tubular member51 may be in fluid communication with blood, seal 52 prevents blood fromflowing out of the system 10. Seal 52 may be disposed anywhere along alength of the compression tubular member 51. The length of compressionmember 51 from the seal 52 to a distal tip thereof is substantiallyshorter than a length of the locating/temporary hemostasis assembly 11,approximately half the length. Locating assembly 11 may have a length ina range from about 4 inches to about 18 inches, preferably from about 8inches to about 12 inches. This ensures that the handle assembly 14 ofassembly 11 can be pushed through seal 52 when member 11 is positionedin the vessel.

The second flexible tubular member 53 may be concentric with and containthe first tubular member 51. This second tubular member 53 may expanddistally the full length of the first tubular member 51. The two tubularmembers 51 and 53 may bifurcate proximally as depicted by arrow 54. Itwill be appreciated that these two tubular members 51 and 53 may befabricated from a multi-lumen tubing using common extrusion processes.In general, all tubular members 12, 51, and 53 may be formed frompolyester (e.g., polyethylene terephthalate), PEBAX™, PEEK™, nylon,polyvinyl chloride, and like medical grade materials. A distal end ofthe compression assembly 50 is equipped with a compression balloon 55which is attached at a distal end 56 and a proximal end 57 thereof. Theballoon 55 is in communication with an inflation lumen 58 that is formedbetween the two tubular members 51 and 53 of the compression assembly50. A proximal end of the second tubular member 53 is equipped with aluer lock 59 for attaching a syringe 60 or the like to pump air orfluids, such as saline solution, into compression balloon 55 for thepurpose of inflating the balloon. The inflation assembly may also beequipped with a stopcock 61, distal to luer lock 59, that maintains thepressure once the balloon is inflated to its desired pressure. Thedevice may also include a pressure relief valve 62 that automates andvisually verifies when the desired pressure of the compression balloon55 is reached. The pressure relief valve 62 would take the guess workout of the required amount of pressure to be applied to the compressionballoon 55.

Referring now to FIG. 1D, the interaction of assemblies 11 and 50 of theclosure system 10 is shown. Locating/temporary hemostasis assembly 11slides inside compression assembly 50 such that the distal tip 56 ofcompression balloon 55 gets located at a fixed distance proximal tolocating expansible member 13 of assembly 11. The locating process maybe achieved by aligning visual marks on the two assemblies, such asaligning mark 18 of locating assembly 11 to be just outside seal 52 ofcompression assembly 50. Alternatively, the locating process may beachieved as a result of a mechanical interference or a latchingmechanism. The latching mechanism may be designed to provide an audio ora tactile feedback when the two tubular assemblies 11 and 50 latch. Oncethe two assemblies are latched, the latching mechanism can allowassembly 11 to move distally with minimal force. This detent, however,resists further forward movement of compression assembly 50 relative toassembly 11. The distal movement of assembly 11 relative to compressionmember 50 may be desirable when the compression balloon 55 is inflated.The inflation of the compression balloon 55 may push the vessel walldistally. Having assembly 11 move with minimal force, such as 1 to 20ounces, preferably 5 to 10 ounces, in the same direction would eliminateexerting stress on the vessel wall.

The expansible member 13 of the locating assembly 11 may assume avariety of forms. Some are deployed by pushing the deployment means 15forwardly. FIGS. 2A and 2B show an example of such a push typeexpansible member 13′ in contracted and deployed states, respectively.In particular, push/pull member 15 is pushed distally as depicted byarrow 9 to deploy fan-like expansible member 13′. Others may have thedeployment means 15 connected to a distal end of the expansible member13″ and to deploy the expansible member 13″ the deployment means ispulled back. FIGS. 3A and 3B illustrate an example of a pull typeexpansible member 13″ in contracted and deployed states, respectively.In particular, push/pull member 15 is pulled proximally as depicted byarrow 8 to deploy hooks or prongs 13″.

The deployed expansible member 13 produces a cross-sectional diameterthat is substantially large so that when the assembly 11 is pulled backin the vessel and the expansible member is seated against the vesselwall, it can produce substantial resistance to the movement of theexpansible member and therefore locate the assembly 11 against thepuncture site inside the vessel lumen. The expansible member 13, indeployed state, may produce a feature that is in a range from about 0.05inch to about 0.5 inch in diameter, preferably from about 0.15 inch toabout 030 inch. The expansible member 13 may be made from suitablemetals such as stainless steel, shape memory material, superelasticmaterial (e.g., NITINOL™ wire), etc. which can be elongated, contracted,or constrained without permanent deformation, but at body temperature,when freed or unconstrained returns to the expanded configuration.

Compression balloon 55 is designed to perform various functions andexhibit particular behavior, specifically in the case of pre-formed orpre-molded balloons. For example, the proximal end 57 of the balloon 55may be made in a conical form. FIG. 4A illustrates an example of asimple conical shaped compression balloon 70. During inflation of theballoon 70 the portion closer to the apex 71 inflates to its maximumdiameter first, and then inflation is propagated distally. Thisinflation process may aid in stabilizing the balloon 70 in the tissueand prevents lateral displacement of the compression assembly 50.

Referring now to FIG. 5A, the balloon may alternatively comprise aplurality of concentric folds that would be unfolded when pressurized.FIG. 5A illustrates a compression balloon 80 prior to assemblyattachment. Balloon 80 incorporates a plurality of folds 81. The processof unfolding causes the distal end 82 of the balloon to move forward,compressing the tissue in front of the balloon against the puncturesite. Feature 83, just proximal to the balloon attachment area 84, foldsover the attachment point as the balloon unfolds forwardly to allow forballoon elongation. FIGS. 5B and 5C illustrate the attached balloon 80prior to inflation and after inflation, respectively.

Referring now to FIG. 6A, yet another design of the compression balloonprior to attachment to the assembly is shown. Balloon 85 is folded andstacked between two attachment points 86 and 87. FIG. 6B illustratesthis balloon 85 at inflation. The design and attachment of the balloon85 may allow for the forward tissue compression. It also can form aconcave distal end 88 at full inflation. The concave feature 88 of theballoon 85 may allow for more coagulant to form at the puncture site.

Referring now to FIG. 7A, another example of a balloon prior toattachment to the assembly is shown. Since the entry of the sheath tothe vessel wall may not be perpendicular, the balloon may be moldedasymmetrically. With balloon 90 at full inflation, more elongation isobtained on the top superior side relative to the bottom inferior side.This may be achieved by incorporating deeper folds 91 in the balloonmaterial on the side with greater elongation requirements and shallowerfolds 92 on the opposite side. Feature 93 just proximal to theattachment point 94 may allow for the balloon elongation by folding overthe attachment point 94 when the balloon is pressurized. In such adesign, locating/temporary hemostasis assembly 11 may not be concentricto the compression assembly, but rather offset from the compressionassembly. For example, assembly 11 may be placed closer to the inferiorwall 92 of the compression balloon 90. This offset compensates for turn95 generated during balloon 90 inflation as the result of itsasymmetrical nature, and consequently centers the distal end 96 of theballoon over the puncture site at full inflation, as shown in FIG. 7C.FIG. 7B depicts this balloon design prior to inflation. It should beclear that if the molding process allows, the balloon may be designedwith a distal face at an angle to the assembly shaft similar to theangle that the sheath makes with the vessel wall, to compensate for suchan effect.

Referring back to FIG. 4B, the balloon may be designed or attached suchthat at full inflation, the distal face of the balloon forms a concavesurface with respect to the vessel wall. In a simple conical balloon 70,this may be accomplished by attaching balloon 70 on the assembly shaftat location 72 which is proximal to point 73 where a fully inflated,unconstrained balloon may extend to. In the case of balloon with folds,such as balloons 80 and 90, this may be accomplished by making features83 and 93 shorter than the increase in the length of the balloon as aresult of inflation.

The compression balloon 55, 70, 80, 85, or 90 is generally formed ofmaterials that can withstand elevated pressures. The balloon should bedesigned to withstand pressures high enough to dilate the subcutaneoustissue around the tissue track and to be able to compress the tissueagainst the puncture site. Polyethylene, polyethylene terephthalate,polytetrafluroethylene, nylon, polyurethane, silicone, latex, polyvinylchloride, and thermoplastic elastomer with different durometers, areexamples of such materials. These materials offer differentcharacteristics. Some can be molded to exhibit a specific shape wheninflated, and some are elastomeric. The advantage of elastomericmaterials over other high pressure materials is their elongationcharacteristics. Therefore, elastomeric materials may have a smallerprofile prior to inflation. However, they may not be pressurized ashigh. The compression balloon may also incorporate radio-opaquematerials, so that balloon placement may be imaged and verified. It mayalso be desirable to deliver electrical energy, such as radio frequencyenergy and the like, to the puncture site to accelerate the hemostasisprocess. In such a case the compression balloon may be coated withelectrically conductive material to provide means of delivering suchenergy.

It should also be noted that the compression member, thus far referredto as compression balloon, may be composed of an expansible member thatis fully or partially covered by a membrane. This compression assemblywhen deployed can provide for the radial dilation of the surroundingtissue, as well as forward expansion resulting in tissue compression.The deployment of this expansible member may be accompanied by injectionof air or fluid to assist in the expansion of the expansible member andtissue compression process. Such an embodiment is described in greaterdetail in co-pending U.S. patent application Ser. No. 10/718,504,assigned to the assignee of the present application and incorporatedherein by reference.

FIGS. 8A through 8G illustrate operation of closure system 10 describedabove with a symmetrical compression balloon 80. At the completion of acatheterization procedure, a sheath 100 remains in place as shown inFIG. 8A. Assembly 11 of the closure system 10 is slidably receivedwithin the sheath 100, as shown in FIG. 8B. Assembly 11 is fed throughthe sheath 100 far enough to guarantee that the distal end of theexpansible member 13 is outside the sheath 100 and in the lumen 101 ofblood vessel. This may be indicated by marking 19 on the outside oftubular member 12. Once in place, the expansible member 13 is deployedby pushing the deployment handle 14 forwardly, as in the case of a pushtype locating mechanism (FIGS. 2A and 2B). Locating assembly 11 is thenpulled back until expansible member 13 is placed against the distal tipof the sheath 100. This would be indicated as resistance is felt whenassembly 11 is pulled back. The sheath 100 is then slowly removed fromthe body, and over assembly 11, and discarded. As shown in FIG. 8C,assembly 11 would be left behind with locating member 13 against vesselwall 102 at the puncture site 103, inside the vessel, and temporaryhemostasis plug 16 remains lodged in the vessel wall at 103, preventingblood from leaking out.

Referring now to FIG. 8D, the proximal end of assembly 11 is then pushedthrough the distal end of compression assembly 50 and fed through thelumen of its tubular member 51 until it penetrates seal 52, and exitsthe proximal end of assembly 50. Compression assembly 50 is then guidedover tubular member 12 of locating/temporary hemostasis assembly 11through an opening in skin 104, through tissue tract 105, until itsdistal end 97 is placed at a predetermined distance 106 from the vesselwall 102 and against subcutaneous tissue 98. This positioning may beindicated by marking 18 on tubular member 12. The compression balloon isthen inflated to its optimum pressure so as to provide targeted microcompression, as shown in FIG. 8E. Tissue compression 107 over thepuncture site 103 of the vessel wall 102 can now provide the means forhemostasis. Assembly 11 of the closure device is then contracted andremoved from the body through the lumen of the compression assembly 50,as shown in FIG. 8F. The compression assembly 50 may remain in the bodyas long as necessary to allow the body's own natural wound healingmechanism to achieve hemostasis. The balloon 80 is then deflated, andthe compression assembly 50 is removed, as shown in FIG. 8G.

FIGS. 9A through 9C illustrate another system 110 embodiment forhemostasis of a puncture site in a body lumen constructed in accordancewith the principles of the present invention. The system 110 comprises acatheter assembly 120 and an inflation assembly 140. Catheter assembly120 has a cross-sectional profile smaller than the sheath 100. FIG. 9Ashows the catheter assembly 120 which comprises a locating/temporaryhemostasis mechanism 121, 124 (and means for deployment) integrated witha compression balloon 126 and a second tubular member 127 for inflatingthe compression balloon 126. The catheter assembly 120 includes locatingexpansible member 121 and means for its deployment and retraction,namely push/pull member 122 and handle assembly 123. Member 122 exits aproximal end of the first tubular member 125 through seal 131. Sincefirst tubular member 125 is in communication with blood, seal 131prevents blood from flowing out. The movement of handle assembly 123 maybe limited by the proximal end of the first tubular member 125 and byinterference of expansible member 121 with a distal end of tubularmember 125. Movement of plug member 124 and tubular member 125 may belimited by interference of feature 132 with a proximal end of secondtubular member 127 and by interference of plug 124 with a distal end oftubular member 127 at feature 130.

It may be desirable in some embodiments to allow the expansible member121 and the hemostasis plug 124 to move freely forward in a distaldirection when the compression balloon 126 is inflated. Therefore anintermediate position for the relative position of tubular members 125and 127 may be established before feature 132 interferes with theproximal end of tubular member 127. In this position the expansiblemember 121 and the hemostasis plug 124 are deployed and the compressionballoon 126 is placed at the desired distance to the vessel wall 102.This intermediate position may be identifiable by a visual mark or by amechanical detent as described above. It may also be desirable to designthe deployment and contraction mechanism 122 of the expansible member121 and the temporary hemostasis plug 124 so that the temporaryhemostasis plug 124 is deployed first followed by the locating mechanism121. When contracting these members, the locating member 121 isretracted within the hemostasis plug 124 first and then the plug 124 isretracted into second tubular member 127.

Temporary hemostasis plug 124 is at the distal end of the first flexibleelongated tubular member 125. Compression balloon 126 is attached at thedistal end of the second flexible tubular member 127. Second tubularmember 127 terminates in flexible inflation tube 128. Second tubularmember 127 is in fluid communication with compression balloon 126through ports 129. The two tubular members 125 and 127 may be moveablerespect to each other, as shown in FIG. 9A. Expansible member 121 andtemporary hemostasis plug 124 may be retracted and housed inside thesecond tubular member 127 at feature 130 after the compression balloon126 has been inflated. System 110 may also be designed to have the twotubular members 125 and 127 be fixed relative to each other. In such acase, the inflation process and distal expansion of compression balloon126 may cause members 121 and 124 to be retracted and removed from thevessel lumen 101 and the vessel wall 102. FIG. 9B shows inflationassembly 140 which generally comprises a quick connect 141 that connectsinflation mechanism 140 to inflation tube 128 of catheter assembly 120,a pressure relief valve 142, a stopcock 143, and a luer lock 144 forattaching syringe 145.

Operation of system 110 with the sheath 100 still in place involvespositioning catheter assembly 120 through the sheath 100, until a tip ofthe catheter assembly 120 is outside of the sheath 100 and is in thevessel lumen 101. As shown in FIG. 9A, this may be indicated by mark 133on the second tubular member 127. The first tubular member 125 is movedforward to expose plug 124. Handle assembly 123 is then moved forward todeploy the expansible member 121. Catheter assembly 120 is then pulledback until resistance is felt, indicating that expansible member 121 isat the distal end of the sheath 100. The sheath is then pulled back, andslowly removed from the body, over the entire length of the catheter120, leaving expansible member 121 against the inside of the vessel wall102, and with hemostasis plug 124 lodged in the puncture site 103 in thevessel wall 102. The sheath 100 can be discarded. The compressionballoon 126 is now located and fixed at a predetermined distance 106from the vessel wall 102.

Inflation assembly 140 is then connected to inflation tube 128 via quickconnect 141 as illustrated in FIG. 9C. Syringe 145 containing air,saline, other agents (e.g., clot promoting solutions), or a combinationthereof is connected to luer lock 144. With stopcock 143 ininflation/deflation position the balloon 126 is inflated to the desiredinflation pressure, causing radial and axial expansion of the balloon126 and causing subcutaneous tissue compression 107 against the puncturesite 103, overcoming the blood pressure and producing hemostasis. Theinflation process is complete when air or fluid starts to exit from thepressure relief valve 142. Stopcock 143 is turned to hold positionallowing the pressure to be maintained inside compression balloon 126.Handle assembly 123 is then manipulated to sequentially retract thelocating member 121 first and then the temporary hemostasis plug 124.The compression balloon 126 is allowed to remain inflated for a periodof time against the subcutaneous tissue 98. Once the desired period ofcompression time is elapsed, stopcock 143 is put in theinflation/deflation position. The syringe 145 can be used to facilitateremoval of the medium from the compression balloon 126 and furthermorecollapse the balloon 126 around the tubular member 127. Catheterassembly 120 is then removed from the body.

FIG. 10 illustrates yet another system 110′ embodiment for hemostasis ofa puncture site in a body lumen constructed in accordance with theprinciples of the present invention. This is an integrated, unitarystructure 120, containing all the working elements as discussed abovewith reference to FIGS. 9A through 9C. In this embodiment, the inflationassembly 140′ of system 110′ has a profile that is substantially greaterthan the sheath 100. As such, the second flexible elongated tubularmember 127 is made of sufficient length to allow for complete removal ofthe sheath 100 from the body when the locating expansible member 121 andtemporary hemostasis plug 124 are deployed. The sheath 100 stays withthe assembly 120 until hemostasis is achieved and the system 110′ isremoved.

FIGS. 11A through 11C illustrate yet another system 200 embodiment forhemostasis of a puncture site in a body lumen constructed in accordancewith the principles of the present invention. This is also an integratedstructure, including several of the working elements discussed abovewith reference to FIGS. 9A through 9C. For example, the functions oflocating expansible member 151, push/pull member 152, temporaryhemostasis plug 153, compression balloon 154, seal 155, and handleassembly 156 are similar to those described above. As depicted in FIG.11C, the pumping mechanism includes a compression seal 157 and a pumphandle 158. The pump assembly 157, 158 compresses the air in piston 159to inflate compression balloon 154. Balloon 154 is in fluidcommunication with 159 through opening 160, as depicted in FIG. 11B.System 200 has a cross-sectional profile that is smaller than the insidediameter of the sheath 100 being used. Therefore the sheath 100 cancompletely slide off over the system 200 when the locating expansiblemember 151 and temporary hemostasis plug 153 have been deployed and areplaced in the vessel appropriately.

Although certain exemplary embodiments and methods have been describedin some detail, for clarity of understanding and by way of example, itwill be apparent from the foregoing disclosure to those skilled in theart that variations, modifications, changes, and adaptations of suchembodiments and methods may be made without departing from the truespirit and scope of the invention. Therefore, the above descriptionshould not be taken as limiting the scope of the invention which isdefined by the appended claims.

What is claimed is:
 1. A system for hemostasis of a puncture site in abody lumen, the device comprising: a locating member having a proximalend and a distal end and an expansible member disposed on the distal endthereof; and a compression member at least partially coaxial with thelocating member, the compression member having a proximal end and adistal end and an expansible element disposed at the distal end thereof,wherein a distal end of the expansible element is postionable at apredetermined distance away from a wall of the body lumen.
 2. The systemof claim 1, further comprising deployment means coupleable to theproximal end of the locating member so as to move the expansible memberbetween a contracted configuration and an expanded configuration.
 3. Thesystem of claim 2, wherein the expansible member in the expandedconfiguration has a diameter in a range from about 0.05 inch to about0.5 inch.
 4. The system of claim 3, wherein the expansible member in theexpanded configuration has a diameter in a range from about 0.15 inch toabout 0.30 inch.
 5. The system of claim 1, wherein the expansible membercomprises stainless steel, shape memory material, or superelasticmaterial.
 6. The system of claim 1, further comprising a temporaryhemostasis member coupleable to the distal end of the locating member.7. The system of claim 6, wherein the expansible element is disposedbetween the distal end of the compression member and a proximal end ofthe temporary hemostasis member.
 8. The system of claim 1, furthercomprising a deformable membrane at least partially disposed over theexpansible member.
 9. The system of claim 1, wherein the locating memberand compression member form an integrated catheter assembly.
 10. Thesystem of claim 1, wherein the compression member remains proximal adistal end of the expansible member.
 11. The system of claim 10, furthercomprising mechanical or visual means on the locating member orcompression member.
 12. The system of claim 10, wherein thepredetermined distance is in a range from about 0.05 inch to about 0.5inch.
 13. The system of claim 12, wherein the predetermined distance isin a range from about 0.2 inch to about 0.3 inch.
 14. The system ofclaim 10, wherein the compression member is fixed relative to thelocating member.
 15. The system of claim 10, wherein the compressionmember is moveable relative to the locating member.
 16. The system ofclaim 1, wherein the locating member is laterally offset from an axis ofthe compression member.
 17. The system of claim 1, wherein theexpansible element comprises a balloon.
 18. The system of claim 17,wherein the balloon comprises one or more materials selected from thegroup consisting of polyethylene, polyethylene terephthalate,polytetrafluroethylene, nylon, polyurethane, silicone, latex, polyvinylchloride, and thermoplastic elastomer.
 19. The system of claim 17,wherein the balloon is pre-formed or pre-molded symmetrically orasymmetrically.
 20. The system of claim 17, wherein the balloon has adeployed configuration comprising a conical shape.
 21. The system ofclaim 17, wherein the balloon comprises a plurality of concentric foldsthat are unfolded in a deployed configuration.
 22. The system of claim17, wherein the balloon has a deployed configuration comprising aconcave distal end.
 23. The system of claim 17, wherein the balloonfurther comprises a radio-opaque material.
 24. The system of claim 17,further comprising a coating on an outer surface of the balloon.
 25. Thesystem of claim 24, wherein the coating comprises electricallyconductive material for the delivery of energy.
 26. The system of claim25, wherein the energy comprises radio frequency energy or microwaveenergy.
 27. The system of claim 24, wherein the coating comprises a clotpromoting or anti-infection agent.
 28. The system of claim 17, whereinthe balloon comprises a semi-permeable membrane.
 29. The system of claim17, further comprising an inflation assembly coupleable to the proximalend of the compression member and in communication with the balloon. 30.The system of claim 29, wherein the inflation assembly comprises asource of at least air, fluid, clot promoting agent, anti-infectionagent, or radio-opaque medium.
 31. A device for hemostasis of a puncturesite in a body lumen, the device comprising: a first tubular memberhaving a proximal end and a distal end; a second tubular member having aproximal end and a distal end and at least partially coaxial with thefirst tubular member so as to define an inflation lumen therebetween; aballoon disposed at the distal ends of the first and second tubularmembers and in communication with the inflation lumen, wherein a distalend of the balloon is postionable behind a locator and at apredetermined distance away from a wall of the body lumen.
 32. Thedevice of claim 31, wherein the predetermined distance is in a rangefrom about 0.05 inch to about 0.5 inch.
 33. The device of claim 32,wherein the predetermined distance is in a range from about 0.2 inch toabout 0.3 inch.
 34. The device of claim 31, wherein the ballooncomprises one or more materials selected from the group consisting ofpolyethylene, polyethylene terephthalate, polytetrafluroethylene, nylon,polyurethane, silicone, latex, polyvinyl chloride, and thermoplasticelastomer.
 35. The device of claim 31, wherein the balloon is pre-formedor pre-molded symmetrically or asymmetrically.
 36. The device of claim31, wherein the balloon has an expanded configuration comprising aconical shape.
 37. The device of claim 31, wherein the balloon comprisesa plurality of concentric folds that are unfolded in an expandedconfiguration.
 38. The device of claim 31, wherein the balloon has anexpanded configuration comprising a concave distal end.
 39. The deviceof claim 31, wherein the balloon further comprises a radio-opaquematerial.
 40. The device of claim 31, further comprising a coating on anouter surface of the balloon.
 41. The device of claim 40, wherein thecoating comprises electrically conductive material for the delivery ofenergy.
 42. The device of claim 41, wherein the energy comprises radiofrequency energy or microwave energy.
 43. The device of claim 40,wherein the coating comprises a clot promoting or anti-infection agent.44. The device of claim 31, wherein the balloon comprises asemi-permeable membrane.
 45. The device of claim 31, wherein the ballooncomprises an expansible member and a deformable membrane at leastpartially disposed over the expansible member.
 46. The device of claim31, wherein the balloon is inflatable with air, fluid, clot promotingagent, anti-infection agent, radio-opaque medium or a combinationthereof.